Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®

Last updated: November 28, 2023
Sponsor: Mabscale, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Rosacea

Psoriasis And Psoriatic Disorders

Warts

Treatment

Adalimumab

Humira

Clinical Study ID

NCT06005532
MABPS-3/2020
  • Ages 18-65
  • All Genders

Study Summary

MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®.

The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent.
  2. Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
  3. Established clinical diagnosis plaque psoriasis, lasting at least 6 months before thescreening.
  4. Plaque psoriasis of moderate or severe severity of stable course with:
  • PASI ≥ 12 points;
  • BSA ≥ 10 %;
  • sPGA ≥ 3 points.
  1. Patients who have been shown to undergo systemic therapy and/or patients who have hadinsufficient therapeutic efficacy of at least 1 previous standard systemic therapy forpsoriasis, including phototherapy, therapy with cytostatic and immunosuppressivedrugs, or who have had intolerance to standard systemic therapy.

Exclusion

Exclusion Criteria:

  1. Data on intolerance or hypersensitivity to any components of the drugs, or to anyother human proteins, immunoglobulin preparations.
  2. A history of severe hypersensitivity reactions of any etiology.
  3. Other (other than plaque) forms of psoriasis.
  4. Drug-induced psoriasis.
  5. Data on the use of the Adalimumab or any preparations of monoclonal antibodiesinhibiting TNF-α at any time during life.
  6. The presence of Adalimumab antibodies.
  7. Extensive surgical intervention performed less than 30 days before the screeningperiod, or planned extensive surgical intervention during the study period.
  8. Active or latent tuberculosis
  9. Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or ahistory of multiple myeloma.
  10. Any other malignant neoplasms currently or in anamnesis within the last 5 years, withthe exception of completely removed and/or cured.
  11. Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to thescreening period.
  12. Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C,HIV.
  13. Vaccination with live or attenuated vaccines within 8 weeks before the screeningperiod.
  14. Hepatic and/or renal insufficiency.
  15. Pregnancy or lactation.

Study Design

Total Participants: 494
Treatment Group(s): 2
Primary Treatment: Adalimumab
Phase: 3
Study Start date:
October 02, 2023
Estimated Completion Date:
December 31, 2025

Study Description

Adalimumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients with chronic plaque psoriasis.

This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Connect with a study center

  • Regional dermatovenerologic dispensary

    Barnaul,
    Russian Federation

    Active - Recruiting

  • Chelyabinsk Regional Clinical Dermatovenerologic Dispensary

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • Interregional Clinical Diagnostic Center

    Kazan',
    Russian Federation

    Site Not Available

  • City clinical hospital n.a.Botkin

    Moscow,
    Russian Federation

    Site Not Available

  • Rheumatology research Instititue n.a.Nasonova

    Moscow,
    Russian Federation

    Site Not Available

  • State Scientific Center of Dermatovenerology and Cosmetology

    Nizhny Novgorod,
    Russian Federation

    Site Not Available

  • Reafan

    Novosibirsk,
    Russian Federation

    Site Not Available

  • New Clinic

    Pyatigorsk,
    Russian Federation

    Site Not Available

  • Dermatovenerologic dispensary N10

    Saint Petersburg,
    Russian Federation

    Site Not Available

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